Healix Infusion Therapy, Inc.: Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.

Agency Publication Date: August 21, 2014

Affected Products

Product: fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478 NDC 75901-8008-90

Lot 7088-0 Exp. 07/14

Lot Numbers:

7088-0

Product: fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8002-04

Lots 7230-0, 7269-0 Exp. 08/14

Product: fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc., at 866-299-4826, 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8007-02

Lot 7250-0 Exp. 08/14

Lot Numbers:

7250-0

Product: fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478 NDC 75901-8008-33

Lots 7083-0, 7202-0, 7222-0 Exp. 08/14

Product: fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale, Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8015-04

Lot 7257-0 Exp. 08/14

Lot Numbers:

7257-0

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 69056

Status: Resolved

Manufacturer: Healix Infusion Therapy, Inc.

Manufactured In: United States

Units Affected: 4 products (50 syringes; 48 bags; 12 bags; 220 syringes)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot 7088-0 Exp. 07/14

Lot Numbers:

7088-0

Lots 7230-0, 7269-0 Exp. 08/14

Lot 7250-0 Exp. 08/14

Lot Numbers:

7250-0

Lots 7083-0, 7202-0, 7222-0 Exp. 08/14

Lot 7257-0 Exp. 08/14

Lot Numbers:

7257-0